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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01203826 |
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Date of registration:
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15/09/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Extension Study of Protocol ENB-006-09 - Study of Asfotase Alfa in Children With Hypophosphatasia (HPP)
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Scientific title:
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Extension Study of Protocol ENB-006-09 Evaluating the Long-term Safety and Efficacy of Asfotase Alfa (Human Recombinant Tissue Nonspecific Alkaline Phosphatase Fusion Protein) in Children With Hypophosphatasia (HPP) |
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Date of first enrolment:
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April 2010 |
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Target sample size:
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12 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01203826 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Canada
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Compliant and satisfactory completion of Enobia-sponsored clinical trial ENB-006-09
- Written informed consent by parent or other legal guardian prior to any study
procedures being performed
- Parent or other legal guardian willing to comply with study requirements
Exclusion Criteria:
- Clinically significant disease that precludes study participation, in the
Investigator's opinion
- Treatment with an investigational drug other than asfotase alfa
- Enrollment in any study (other than ENB-006-09) involving an investigational drug,
device, or treatment for HPP
- Prior treatment with bisphosphonates
Age minimum:
5 Years
Age maximum:
12 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hypophosphatasia (HPP)
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Intervention(s)
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Biological: Asfotase Alfa
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Primary Outcome(s)
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Skeletal Radiograph Evaluation Using a Qualitative Radiographic Global Impression of Change (RGI-C) Scale Compared to Baseline (Pre-treatment) in Study ENB-006-09.
[Time Frame: At least 72 months of treatment with asfotase alfa]
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Secondary ID(s)
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ENB-008-10
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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